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“For tracking litigation, enforcement, and regulatory developments, Compliance Week
should be your prime source.”- Chief Compliance Officer and VP of Legal Affairs, Arrow Electronics
Drug, Device Companies Face New FDA Electronic Submissions
The Food and Drug Administration is overhauling how it accepts submissions for a host of filing requirements imposed on drug and medical device makers. For many, this will be the first time the submissions have ever been filed electronically. While the move away from paper documents may ultimately be advantageous ...
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News BriefBecton Dickinson pays $175M for misleading investors about flawed IV pump system
Becton Dickinson medical device company will pay $175 million for “repeatedly” misleading investors about its Alaris infusion pump, a product the company knew was flawed and was sold without the required patient-safety approvals, the Securities and Exchange Commission said.
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News BriefSEC levies no fine against Kiromic BioPharma after material omissions self-disclosure
Kiromic BioPharma will pay no fine to the Securities and Exchange Commission after self-reporting that it failed to disclose material information about two cancer drugs to investors.